CN100463677C - Preparation of nedaplatin freeze-dried powder injection - Google Patents
Preparation of nedaplatin freeze-dried powder injection Download PDFInfo
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- CN100463677C CN100463677C CNB2007100203260A CN200710020326A CN100463677C CN 100463677 C CN100463677 C CN 100463677C CN B2007100203260 A CNB2007100203260 A CN B2007100203260A CN 200710020326 A CN200710020326 A CN 200710020326A CN 100463677 C CN100463677 C CN 100463677C
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Abstract
This invention relates to a preparation method of freeze-dried injection of nedaplatin.nedaplatin freeze-dried injection prepared with the inventive method can be used as therapeutic drug of cancer. The invention improves the stability of nedaplatin during lyophilization and shortens the period of lyophilization through adding ethanol during preparation process. the preparation method comprises adding water for injection 80% of nedaplatin into nedaplatin, stirring for dissolving, adding dextran, stirring for dissolving, determing the content of intermediate, adding ethanol 1-10% of the cumulative volume of the solution, adding water for injection to full dose, filtrating with 0.22 mu m millipore filter under aseptic condition, encapsulating in sirin bottle, plugging, freeze drying, rolling the opening, testing, and packaging. The optimum amount of ethanol is 1-5% of cumulative volume of the solution.
Description
Technical field
What the present invention relates to is a kind of preparation method of freeze-dried powder injection of nedaplatin, can be used as the medicine of incidence cancer, small cell carcinoma of lung, lung non-small cell carcinoma, the esophageal carcinoma, bladder cancer, carcinoma of testis, ovarian cancer, cervical cancer etc. by the freeze-dried powder injection of nedaplatin of this method preparation.
Background technology
Since the second half in 20th century, the morbidity of cancer and death all are ascendant trend year by year, and especially since 70 years 20th century, the pathogenesis of cancer number is with the speed increase of average annual 3-5%, and the death of cancer has become one of human seven big important causes of the death.About 6,200,000 according to the death toll of WHO report cancer in 1997, occupy after infectious disease and the cardiovascular diseases, classify human dead the 3rd as.WHO holds tumor control planning meeting in London, this Director Of Plans Karol Sikora (France, Lyons) estimates the year two thousand twenty, the cases of cancer that the whole world nearly 2,000 ten thousand is new estimates that by present mortality rate expectation will have cancer patient's death new about 1,200 ten thousand.
Nedaplatin is the antineoplastic agent of the wild adopted company of Japanese salt exploitation, get permission listing first June nineteen ninety-five, commodity are called Aqupla, are used for the treatment of tumor of head and neck, minicell and nonsmall-cell lung cancer, esophageal carcinoma, bladder cancer, carcinoma of testis, ovarian cancer, cervical cancer.The toxicity spectrum of nedaplatin (Nedaplatin) is different with cisplatin, and its dose-limiting toxicity is the thrombocytopenia due to the bone marrow depression.But its nephrotoxicity and gastrointestinal side effect and cisplatin relatively decrease, no cross resistance, and selectivity discharges medicine and good advantages such as solubility.Find in the clinical trial that nedaplatin is effective to extensive solid tumor, to the effective percentage of tumor of head and neck more than 40%, be better than cisplatin, to the esophageal carcinoma effective percentage greater than 50%, than cisplatin high about 20%, cervical cancer also there is effective percentage more than 40%, for these tumor patients provide new effective selection of clinical.
It is best that nedaplatin and existing other antitumor platinum-like compounds are compared dissolubility, molten in the water part omitted, almost insoluble in most of organic solvents such as methanol, ethanol, but less stable, destructible in acidity or alkaline solution, only stable in neutral solution.High temperature can make nedaplatin solution destroy, and produces black precipitate, and illumination also can exert an influence to nedaplatin.If freeze-dried powder injection of nedaplatin is without the skeleton agent, and it is netted that sample is, and a shake is promptly broken, and is excessive as vacuum in the freeze-drying process, easily taken away.Select for use usual excipients mannitol as the freeze-dried powder injection of nedaplatin sample of skeleton agent preparation through long term test 12 months, color sample is deepened gradually, pinkiness, related substance slightly increases.The freeze-dried powder injection of nedaplatin stability that adopts dextran to do skeleton agent preparation improves greatly, (24 months) are stable for a long time preserves, but increase along with the dextran consumption, solution viscosity increases, and it is difficult that water sublimed becomes, and freeze-drying time prolongs, be prone to defective profiles such as layering and atrophy, the part freeze-dried powder injection of nedaplatin is destroyed in freeze dried temperature-rise period because moisture can not distil smoothly, the color grizzle, even in melt solution, produce black precipitate.
Summary of the invention
The objective of the invention is to provide a kind of preparation method of freeze-dried powder injection of nedaplatin at above weak point, can control the crystallization of nedaplatin solution in the pre-freeze process by this method, minimizing is because of adding the water sublimed difficulty that dextran causes the solution viscosity increase, shorten freeze-drying time, avoid occurring defective profiles such as layering and atrophy, it is destroyed in freeze dried temperature-rise period to have eliminated freeze-dried powder injection of nedaplatin fully, the color grizzle, even in melt solution, produce the phenomenon of black precipitate.
The chemical name of nedaplatin is: (Z)-diamino (hydroxyacetic acid-O1 ,-O2) platinum, structural formula is:
Molecular formula is: C
2H
8N
2O
3Pt, molecular weight: 303.18.
Nedaplatin is molten in the water part omitted, almost insoluble in most of organic solvents such as methanol, ethanol, but we find unexpectedly, by in the preparation process (process for preparation) of freeze-dried powder injection of nedaplatin, adding ethanol, though can the dissolubility of nedaplatin not exerted an influence, can improve the performance in freezing dry process of nedaplatin solution greatly.
A kind of preparation method of freeze-dried powder injection of nedaplatin is to adopt following scheme to realize:
A kind of preparation method of freeze-dried powder injection of nedaplatin has added ethanol in process for preparation.
A kind of preparation method of freeze-dried powder injection of nedaplatin, concrete preparation process is:
Getting nedaplatin puts in the container, the water for injection that adds 80% amount, stirring makes its dissolving and mix homogeneously, add dextran again, stirring makes its dissolving and mix homogeneously, measure intermediate content, qualified back adds ethanol, adds alcoholic acid amount and accounts for 1%～10% of overall solution volume, reuse water for injection is settled to full dose, under aseptic condition, to clear and bright, the filtrate fill is in aseptic cillin bottle with 0.22 μ m filtering with microporous membrane, part is butyl rubber bung beyond the Great Wall, freeze dryer is sent in sabot, closes chamber door, open freeze dryer, utilize conduction oil that flaggy is freezed, the product relaxing the bowels with purgatives of warm nature of making falls, when sample reaches eutectic point (-10 ℃ approximately), when continuing freezing highest grade temperature and being lower than-25 ℃～-45 ℃, stop board is cold, and the open cold condenser is when condenser temperature reaches-40 ℃～-50 ℃, open vacuum system, begin the distillation that heats up, the product temperature control is per hour being risen 2～3 ℃, when the product temperature rise reaches more than 10 ℃, the product temperature of making per hour rises 4～5 ℃, final drying temperature product temperature is 30 ℃～40 ℃, keeps this temperature after 3～6 hours, tamponade, outlet, roll mouth, quality inspection, packing.
Consider the influence of ethanol, add alcoholic acid amount and preferably account for 1%～5% of overall solution volume vacuum equipment in the lyophilizing unit.
The preparation method of a kind of freeze-dried powder injection of nedaplatin of the present invention, can control the crystallization of nedaplatin solution in the pre-freeze process by this method, minimizing is because of adding the water sublimed difficulty that dextran causes the solution viscosity increase, shorten freeze-drying time, avoid occurring defective profiles such as layering and atrophy, it is destroyed in freeze dried temperature-rise period to have eliminated freeze-dried powder injection of nedaplatin fully, the color grizzle, even in melt solution, produce the phenomenon of black precipitate.Improved the stability of freeze-dried powder injection of nedaplatin in preparation process greatly, the freeze-dried powder injection of nedaplatin its related substances of preparation gained is lower, the quality stable homogeneous.Because moisture drying is thorough, moisture evenly the moisture fluctuation is little, makes freeze-dried powder injection of nedaplatin more stable in storage and transportation.Preparation technology of the present invention is simple, convenient feasible, good reproducibility, be easy to realize industrialized great production, owing to shortened freeze-drying time greatly, make the production cycle shorten, reduced defective profiles such as layering and atrophy simultaneously, avoided freeze-dried powder injection of nedaplatin destroyed in freeze dried temperature-rise period, the color grizzle, even in melt solution, produce the phenomenon of black precipitate, and make percent defective reduce, reduced the difficulty of lamp inspection operation inspection rejects, saved manpower, the short production cycle, lower percent defective and lower human cost reduce production cost significantly, thereby can produce considerable economic and social benefit.
The specific embodiment
Further specify the present invention below by embodiment.Should correct understanding be: embodiments of the invention are only used for the present invention is described and provide, rather than limitation of the present invention, so, under method prerequisite of the present invention, simple modifications of the present invention is all belonged to the scope of protection of present invention.
Embodiment 1:
Commonsense method prepares freeze-dried powder injection of nedaplatin (10mg specification)
Prescription
Get the recipe quantity nedaplatin and put in the container, add the water for injection of 80% amount, stir and make its dissolving and mix homogeneously, add the recipe quantity dextran again, stir and make its dissolving and mix homogeneously, measure intermediate content, qualified back adds water for injection and is settled to full dose, and is under aseptic condition, extremely clear and bright with 0.22 μ m filtering with microporous membrane, the filtrate fill is in aseptic cillin bottle, and part is butyl rubber bung beyond the Great Wall, sabot, send into freeze dryer, close chamber door, open freeze dryer, utilize conduction oil that flaggy is freezed, the product relaxing the bowels with purgatives of warm nature of making falls, when sample reaches eutectic point (-10 ℃ approximately), when continuing freezing highest grade temperature and being lower than-25 ℃, stop board is cold, and the open cold condenser is when condenser temperature reaches-40 ℃, open vacuum system, begin the distillation that heats up, the product temperature control is per hour being risen 2～3 ℃, when the product temperature rise reaches more than 10 ℃, the product temperature of making per hour rises 4～5 ℃, final drying temperature product temperature is 35 ℃, keeps this temperature after 3 hours, tamponade, outlet, roll mouth, quality inspection, packing promptly gets freeze-dried powder injection of nedaplatin.
Embodiment 2:
Commonsense method prepares freeze-dried powder injection of nedaplatin (50mg specification)
Prescription
Get the recipe quantity nedaplatin and put in the container, add the water for injection of 80% amount, stir and make its dissolving and mix homogeneously, add the recipe quantity dextran again, stir and make its dissolving and mix homogeneously, measure intermediate content, qualified back adds water for injection and is settled to full dose, and is under aseptic condition, extremely clear and bright with 0.22 μ m filtering with microporous membrane, the filtrate fill is in aseptic cillin bottle, and part is butyl rubber bung beyond the Great Wall, sabot, send into freeze dryer, close chamber door, open freeze dryer, utilize conduction oil that flaggy is freezed, the product relaxing the bowels with purgatives of warm nature of making falls, when sample reaches eutectic point (-10 ℃ approximately), when continuing freezing highest grade temperature and being lower than-25 ℃, stop board is cold, and the open cold condenser is when condenser temperature reaches-40 ℃, open vacuum system, begin the distillation that heats up, the product temperature control is per hour being risen 2～3 ℃, when the product temperature rise reaches more than 10 ℃, the product temperature of making per hour rises 4～5 ℃, final drying temperature product temperature is 35 ℃, keeps this temperature after 3 hours, tamponade, outlet, roll mouth, quality inspection, packing promptly gets freeze-dried powder injection of nedaplatin.
Embodiment 3:
Getting the recipe quantity nedaplatin puts in the container, the water for injection that adds 80% amount, stirring makes its dissolving and mix homogeneously, add the recipe quantity dextran again, stirring makes its dissolving and mix homogeneously, measure intermediate content, qualified back adds the stirring of recipe quantity ethanol makes mix homogeneously, and reuse water for injection is settled to full dose, under aseptic condition, extremely clear and bright with 0.22 μ m filtering with microporous membrane, the filtrate fill is in aseptic cillin bottle, and part is butyl rubber bung beyond the Great Wall, sabot, send into freeze dryer, close chamber door, open freeze dryer, utilize conduction oil that flaggy is freezed, the product relaxing the bowels with purgatives of warm nature of making falls, when sample reaches eutectic point (approximately-10 ℃), when continuing freezing highest grade temperature and being lower than-25 ℃, stop board is cold, the open cold condenser, when condenser temperature reaches-40 ℃, open vacuum system, begin the distillation that heats up, the product temperature control is per hour being risen 2～3 ℃, when the product temperature rise reached more than 10 ℃, the product temperature of making per hour rose 4～5 ℃, and final drying temperature product temperature is 35 ℃, keep this temperature after 3 hours, tamponade, outlet rolls mouth, quality inspection, packing promptly gets freeze-dried powder injection of nedaplatin.
Embodiment 4:
Getting the recipe quantity nedaplatin puts in the container, the water for injection that adds 80% amount, stirring makes its dissolving and mix homogeneously, add the recipe quantity dextran again, stirring makes its dissolving and mix homogeneously, measure intermediate content, qualified back adds the stirring of recipe quantity ethanol makes mix homogeneously, and reuse water for injection is settled to full dose, under aseptic condition, extremely clear and bright with 0.22 μ m filtering with microporous membrane, the filtrate fill is in aseptic cillin bottle, and part is butyl rubber bung beyond the Great Wall, sabot, send into freeze dryer, close chamber door, open freeze dryer, utilize conduction oil that flaggy is freezed, the product relaxing the bowels with purgatives of warm nature of making falls, when sample reaches eutectic point (approximately-10 ℃), when continuing freezing highest grade temperature and being lower than-25 ℃, stop board is cold, the open cold condenser, when condenser temperature reaches-40 ℃, open vacuum system, begin the distillation that heats up, the product temperature control is per hour being risen 2～3 ℃, when the product temperature rise reached more than 10 ℃, the product temperature of making per hour rose 4～5 ℃, and final drying temperature product temperature is 35 ℃, keep this temperature after 3 hours, tamponade, outlet rolls mouth, quality inspection, packing promptly gets freeze-dried powder injection of nedaplatin.
Embodiment 5:
Prescription
Getting the recipe quantity nedaplatin puts in the container, the water for injection that adds 80% amount, stirring makes its dissolving and mix homogeneously, add the recipe quantity dextran again, stirring makes its dissolving and mix homogeneously, measure intermediate content, qualified back adds the stirring of recipe quantity ethanol makes mix homogeneously, and reuse water for injection is settled to full dose, under aseptic condition, extremely clear and bright with 0.22 μ m filtering with microporous membrane, the filtrate fill is in aseptic cillin bottle, and part is butyl rubber bung beyond the Great Wall, sabot, send into freeze dryer, close chamber door, open freeze dryer, utilize conduction oil that flaggy is freezed, the product relaxing the bowels with purgatives of warm nature of making falls, when sample reaches eutectic point (approximately-10 ℃), when continuing freezing highest grade temperature and being lower than-25 ℃, stop board is cold, the open cold condenser, when condenser temperature reaches-40 ℃, open vacuum system, begin the distillation that heats up, the product temperature control is per hour being risen 2～3 ℃, when the product temperature rise reached more than 10 ℃, the product temperature of making per hour rose 4～5 ℃, and final drying temperature product temperature is 35 ℃, keep this temperature after 3 hours, tamponade, outlet rolls mouth, quality inspection, packing promptly gets freeze-dried powder injection of nedaplatin.
Embodiment 6:
The freeze-dried powder injection of nedaplatin determination of related substances
Measure according to high performance liquid chromatography (Chinese Pharmacopoeia 2000 version two ones)
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; With methanol-0.01mol/L citric acid soln (regulating pH value to 6.0 with triethylamine) is mobile phase (30:70); The detection wavelength is 220nm.Number of theoretical plate calculates by the nedaplatin peak should be not less than 1500.
It is an amount of to get the freeze-dried powder injection of nedaplatin content, adds mobile phase dissolving and dilution and makes the solution that contains nedaplatin 1.0mg among every 1ml, as need testing solution; Precision is measured in right amount, adds the mobile phase dilution and makes the solution that contains 10 μ g among every 1ml, solution in contrast.According to the chromatographic condition under the assay item, precision is measured contrast solution 20 μ l, injects chromatograph of liquid, regulates detection sensitivity, makes the main constituent peak height be about 20～25% of full scale.Precision is measured need testing solution and each 20 μ l of contrast solution again, injects chromatograph of liquid respectively, and the record chromatogram is to 2 times of main constituent peak retention time.As showing impurity peaks, measure each impurity peak area sum except that the adjuvant peak in the need testing solution chromatogram, calculate and promptly get freeze-dried powder injection of nedaplatin related substance percentage composition.
Embodiment 7:
The freeze-dried powder injection of nedaplatin assay
Measure according to high performance liquid chromatography (Chinese Pharmacopoeia 2000 version two ones)
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; With methanol-0.01mol/L citric acid soln (regulating pH value to 6.0 with triethylamine) is mobile phase (30:70); The detection wavelength is 220nm.Number of theoretical plate calculates by the nedaplatin peak should be not less than 1500.
Get the freeze-dried powder injection of nedaplatin content, mixing, precision takes by weighing in right amount, adds mobile phase dissolving and dilution and makes the solution that contains nedaplatin 0.2mg among every 1ml, as need testing solution; Precision is measured 20 μ l and is injected chromatograph of liquid, record chromatogram and peak area; It is an amount of that other gets the nedaplatin reference substance, measures with method, with calculated by peak area, promptly gets the content of freeze-dried powder injection of nedaplatin by external standard method.
Embodiment 8:
The freeze-dried powder injection of nedaplatin determination of water
Get the freeze-dried powder injection of nedaplatin content, measure according to aquametry (Chinese Pharmacopoeia 2000 version two ones).
Embodiment 9:
Respectively prepare 3 batches of freeze-dried powder injection of nedaplatin respectively by embodiment 1～5, check its outward appearance, content, related substance and moisture more respectively, add up above-mentioned assay, manufacturing parameters such as record freeze-drying time, defective profile goods percentage rate, color grizzle goods number and generation black precipitate goods number, it the results are shown in Table 1.
Embodiment 10:
Getting the recipe quantity nedaplatin puts in the container, the water for injection that adds 80% amount, stirring makes its dissolving and mix homogeneously, add the recipe quantity dextran again, stirring makes its dissolving and mix homogeneously, measure intermediate content, qualified back adds the stirring of recipe quantity ethanol makes mix homogeneously, and reuse water for injection is settled to full dose, under aseptic condition, extremely clear and bright with 0.22 μ m filtering with microporous membrane, the filtrate fill is in aseptic cillin bottle, and part is butyl rubber bung beyond the Great Wall, sabot, send into freeze dryer, close chamber door, open freeze dryer, utilize conduction oil that flaggy is freezed, the product relaxing the bowels with purgatives of warm nature of making falls, when sample reaches eutectic point (approximately-10 ℃), when continuing freezing highest grade temperature and being lower than-35 ℃, stop board is cold, the open cold condenser, when condenser temperature reaches-45 ℃, open vacuum system, begin the distillation that heats up, the product temperature control is per hour being risen 2～3 ℃, when the product temperature rise reached more than 10 ℃, the product temperature of making per hour rose 4～5 ℃, and final drying temperature product temperature is 35 ℃, keep this temperature after 4 hours, tamponade, outlet rolls mouth, quality inspection, packing promptly gets freeze-dried powder injection of nedaplatin.
Embodiment 11:
Prescription
Getting the recipe quantity nedaplatin puts in the container, the water for injection that adds 80% amount, stirring makes its dissolving and mix homogeneously, add the recipe quantity dextran again, stirring makes its dissolving and mix homogeneously, measure intermediate content, qualified back adds the stirring of recipe quantity ethanol makes mix homogeneously, and reuse water for injection is settled to full dose, under aseptic condition, extremely clear and bright with 0.22 μ m filtering with microporous membrane, the filtrate fill is in aseptic cillin bottle, and part is butyl rubber bung beyond the Great Wall, sabot, send into freeze dryer, close chamber door, open freeze dryer, utilize conduction oil that flaggy is freezed, the product relaxing the bowels with purgatives of warm nature of making falls, when sample reaches eutectic point (approximately-10 ℃), when continuing freezing highest grade temperature and being lower than-45 ℃, stop board is cold, the open cold condenser, when condenser temperature reaches-50 ℃, open vacuum system, begin the distillation that heats up, the product temperature control is per hour being risen 2～3 ℃, when the product temperature rise reached more than 10 ℃, the product temperature of making per hour rose 4～5 ℃, and final drying temperature product temperature is 25 ℃, keep this temperature after 6 hours, tamponade, outlet rolls mouth, quality inspection, packing promptly gets freeze-dried powder injection of nedaplatin.
Claims (2)
1. the preparation method of a freeze-dried powder injection of nedaplatin is characterized in that preparation process is:
Getting nedaplatin puts in the container, the water for injection that adds 80% amount, stirring makes its dissolving and mix homogeneously, add dextran again, stirring makes its dissolving and mix homogeneously, measure intermediate content, qualified back adds ethanol, adds alcoholic acid amount and accounts for 1%～10% of overall solution volume, reuse water for injection is settled to full dose, under aseptic condition, to clear and bright, the filtrate fill is in aseptic cillin bottle with 0.22 μ m filtering with microporous membrane, part is butyl rubber bung beyond the Great Wall, freeze dryer is sent in sabot, closes chamber door, open freeze dryer, utilize conduction oil that flaggy is freezed, the product relaxing the bowels with purgatives of warm nature of making falls, when sample reaches eutectic point-10 ℃, when continuing freezing highest grade temperature and being lower than-25 ℃～-45 ℃, stop board is cold, and the open cold condenser is when condenser temperature reaches-40 ℃～-50 ℃, open vacuum system, begin the distillation that heats up, the product temperature control is per hour being risen 2～3 ℃, when the product temperature rise reaches more than 10 ℃, the product temperature of making per hour rises 4～5 ℃, final drying temperature product temperature is 30 ℃～40 ℃, keeps this temperature after 3～6 hours, tamponade, outlet, roll mouth, quality inspection, packing.
2. the preparation method of freeze-dried powder injection of nedaplatin according to claim 1 is characterized in that adding alcoholic acid amount and accounts for 1%～5% of overall solution volume.
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| CN103315967B (en) * | 2013-06-18 | 2015-09-30 | 江苏奥赛康药业股份有限公司 | A kind of freeze-dried composition, purposes and preparation method thereof containing nedaplatin |
| CN103599079B (en) * | 2013-11-25 | 2016-06-08 | 江苏奥赛康药业股份有限公司 | Injection lobaplatin pharmaceutical composition and its preparation method |
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Cited By (2)
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| CN101865896A (en) * | 2010-06-28 | 2010-10-20 | 江苏奥赛康药业有限公司 | Method for detecting impurities in nedaplatin |
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Address after: 211112 Jiangsu Province, Nanjing City, Jiangning Science Park Road No. 699 Patentee after: Jiangsu Aosaikang Pharmaceutical Co., Ltd. Address before: 211112 Jiangsu Province, Nanjing City, Jiangning Science Park Road No. 699 Patentee before: Jiangsu Aosaikang Pharmaceutical Co., Ltd. |
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Address after: 211112 Kejian Road, Jiangning Science Park, Nanjing City, Jiangsu Province, 699 Patentee after: Jiangsu Aosaikang Pharmaceutical Co., Ltd. Address before: 211112 Kejian Road, Jiangning Science Park, Nanjing City, Jiangsu Province, 699 Patentee before: Jiangsu Aosaikang Pharmaceutical Co., Ltd. |
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